Role Overview

We are looking for an experienced and dynamic Senior Product & Client Manager with strong domain expertise in Pharmacovigilance (PV) and Drug Safety systems.

The candidate will work closely with the Product Management and Client Management functions, supporting the management and continuous enhancement of Clinevo Safety, our Pharmacovigilance Safety Database product.

The role requires a strong combination of product management, functional expertise, client relationship management and techno-functional knowledge of global drug safety systems.

The candidate will be responsible for understanding client and regulatory requirements, managing product enhancements, coordinating implementation and migration activities, supporting client engagements and ensuring successful delivery of product releases.

Experience with established global safety databases such as Oracle Argus Safety, ArisG, Veeva Vault Safety or other enterprise Pharmacovigilance platforms is highly desirable

.

Key Responsibilities

1. Product Management & Strategy

- Understand the product roadmap, business objectives and functional capabilities of Clinevo Safety.
- Gather, analyse and document product requirements, client requests and regulatory-driven enhancements.
- Prepare Business Requirement Documents (BRDs), Functional Requirement Specifications (FRS) and user stories.
- Coordinate with development and QA teams to ensure requirements are translated into functional specifications and delivered as expected.
- Review product functionality, identify gaps and recommend improvements based on industry practices and client requirements.
- Manage product enhancement requests, prioritization, release planning and delivery timelines.
- Participate in product demonstrations, requirement discussions and feature walkthroughs.
- Ensure product functionality aligns with global Pharmacovigilance business processes and regulatory expectations.

2. Client Relationship & Account Management

- Act as a key point of contact for assigned global pharmaceutical and biotechnology clients.
- Manage client relationships, regular review meetings, project discussions and escalations.
- Understand client business processes and translate their requirements into appropriate product solutions.
- Lead functional discussions, requirement clarification sessions and product demonstrations.
- Manage client expectations, commitments, deliverables and project dependencies.
- Coordinate with internal teams to ensure timely resolution of client issues and requests.
- Prepare project status reports, meeting minutes, action items and management updates.
- Support client onboarding, implementation, go-live and post-production activities.

3. Pharmacovigilance Domain & Regulatory Compliance

- Strong understanding of global Pharmacovigilance processes and drug safety case management.
- Knowledge of ICH E2B(R2) and E2B(R3) regulatory reporting requirements.
- Understanding of global regulatory reporting requirements, including FDA,



EMA, MHRA and other health authorities.
- Knowledge of safety case processing, intake, triage, data entry, medical review, quality control and regulatory submissions.
- Understanding of CIOMS, MedWatch, PADER, PSUR and other regulatory reporting formats.
- Experience with regulatory gateway integrations, electronic submissions and acknowledgements.
- Stay informed about regulatory changes and assess their impact on product functionality.

4. Implementation & Data Migration Management

- Coordinate end-to-end Pharmacovigilance system implementation and client onboarding activities.
- Understand legacy safety database structures and support migration planning.
- Manage migration requirements involving E2B XML (R2/R3), Non-E2B exports and supporting attachments.
- Coordinate with migration, technical and client teams for data extraction, transformation, loading and reconciliation.
- Review migration outputs, identify discrepancies and coordinate resolution.
- Support system configuration, user acceptance testing (UAT), go-live planning and post-implementation activities.
- Track project milestones, deliverables, dependencies and risks.

5. Release Management & Quality Compliance

- Coordinate product release planning, enhancement delivery and release communication.
- Review functional changes and ensure appropriate testing and documentation.
- Support preparation and review of release notes, validation documentation and user guides.
- Coordinate IQ, OQ and PQ activities, where applicable.
- Handle client QA queries, audit observations, deviations, CAPA and Root Cause Analysis (RCA) discussions.
- Ensure product enhancements and changes are appropriately assessed, documented and communicated.
- Work closely with QA and development teams to ensure quality and compliance throughout the product lifecycle.

6. Cross-functional Team Coordination

- Work closely with Development, QA, IT, Migration and Implementation teams.
- Translate business requirements into clear and actionable technical deliverables.
- Track task assignments, progress, priorities and delivery commitments.
- Identify project risks, technical dependencies and potential delivery challenges.
- Coordinate resolution of critical production issues and client escalations.
- Provide functional guidance and domain knowledge to internal teams.

Required Experience & Skills Pharmacovigilance Safety Database Experience

Hands-on functional or techno-functional experience in one or more of the following global safety databases:

- Oracle Argus Safety Strongly preferred.
- ArisG (Aris Global)



Strongly preferred.
- Veeva Vault Safety.
- Other global Pharmacovigilance / Drug Safety databases.

The candidate should have a valuable understanding of the functionality, configuration, workflows, case processing and regulatory reporting capabilities of these systems. Preferred: Experience in multiple safety databases and exposure to safety database migration, implementation or product enhancement projects.

Functional & Domain Expertise

- Minimum 8 -10+ years of experience in the Pharmacovigilance / Drug Safety domain.
- Strong understanding of ICSR case processing and end-to-end safety workflows.
- Knowledge of E2B(R2) and E2B(R3) standards and regulatory reporting.
- Experience with global regulatory submissions and health authority requirements.
- Experience in product implementation, requirement gathering and functional documentation.
- Understanding of safety database configuration and business processes.

Product & Client Management Skills

- Experience in Product Management, Business Analysis, Functional Consulting or Client Management.
- Ability to independently manage client discussions and stakeholder expectations.
- Strong analytical, problem-solving and decision-making capabilities.
- Experience in preparing BRDs, FRS, user stories and functional specifications.
- Ability to coordinate multiple projects, priorities and deliverables.
- Excellent verbal and written communication skills.
- Ability to work with global clients and cross-functional teams.

Technical / Techno-functional Knowledge

- Basic understanding of SQL and relational databases (Oracle preferred).
- Understanding of XML and E2B message structures.
- Knowledge of system integrations, APIs and regulatory gateways.
- Understanding of application architecture and enterprise software environments.
- Familiarity with Agile development, Jira or similar project management tools.

Good to Have

- Experience working with global pharmaceutical companies and CROs.
- Experience in safety database implementation and migration projects.
- Exposure to FDA ESG, EudraVigilance, MHRA and MFDS regulatory gateways.
- Knowledge of GxP, 21 CFR Part 11 and computerized system validation.
- Experience in cloud-based enterprise applications (AWS / Azure).
- Experience in managing product releases and regulatory-driven enhancements.
- Experience in managing client accounts and handling escalations independently.

Key Expectations from the Role

- Independently manage assigned product management and client management responsibilities.
- Act as a functional subject matter expert for Clinevo Safety.
- Bridge the gap between client business requirements and technical implementation.
- Drive product enhancements based on client feedback and regulatory requirements.
- Ensure effective coordination between clients and internal delivery teams.
- Take ownership of assigned client engagements, implementation activities and product deliverables.

📌 Senior Product & Client Manager (Bengaluru)
🏢 Clinevo Technologies
📍 Bengaluru